Actively Recruiting
First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
Led by Daiichi Sankyo · Updated on 2025-07-24
150
Participants Needed
7
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.
CONDITIONS
Official Title
First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated main informed consent form
- Adults 18 years or older
- Diagnosed with advanced (metastatic or unresectable) synovial sarcoma, myxoid/round cell liposarcoma, non-small cell lung cancer (adenocarcinoma or squamous cell), or urothelial carcinoma
- Disease relapsed, refractory, or intolerant to appropriate standard therapies
- Positive for HLA-A*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11
- Measurable disease based on RECIST v1.1 using CT or MRI
- Willing and able to provide adequate pre-treatment or archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1 at screening
- Meets baseline laboratory values within 14 days before starting treatment: ALT and AST ≤3× ULN without liver metastasis or ≤5× ULN with liver metastasis, total bilirubin ≤1.5× ULN (or ≤3× ULN for Gilbert's syndrome), absolute neutrophil count ≥1.5 × 10^9/L, platelet count ≥100 × 10^9/L, hemoglobin ≥8 g/dL, creatinine clearance ≥45 mL/min
- Female participants of childbearing potential must have a negative pregnancy test, agree to use highly effective contraception, not breastfeed during treatment and for 120 days after last dose, and agree to not donate eggs during and after treatment
- Male participants capable of producing sperm must agree to use contraception during treatment and for 120 days after last dose and avoid sperm donation unless azoospermic
You will not qualify if you...
- Prior therapy targeting NY-ESO-1
- Inadequate washout from prior treatments: radiation therapy <4 weeks (or <2 weeks if palliative without abdominal/pelvic radiation), chemotherapy/antibody/immunotherapy <4 weeks, small molecules <2 weeks or 5 half-lives
- Known symptomatic central nervous system metastases, leptomeningeal disease, or spinal cord compression (neurologically unstable)
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, uncontrolled angina, severe congestive heart failure, low left ventricular ejection fraction, or prolonged QTc interval
- Chronic steroid or immunosuppressive treatment exceeding specified doses
- Active other primary malignancies except certain treated cancers without recurrence for 3 years
- Unresolved toxicities from prior cancer treatments except stable Grade 2 toxicities under management
- Known hypersensitivity to biological agents
- History of or active autoimmune disease except certain controlled conditions
- HIV infection (with specific exceptions in Part 2)
- Active or uncontrolled hepatitis B or C infection except controlled cases in Part 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
UZ Leuven Europe Leuven
Leuven, Belgium, 3000
Actively Recruiting
5
Centre Leon Berard
Lyon, France, 6900
Actively Recruiting
6
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam, Netherlands
Actively Recruiting
7
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
C
Contact for Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here